Phase I Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed . (PCTDTcP)

A Randomized,Blind, Positive-controlled Phase I Clinical Trial to Preliminary Evaluate the Safety of DTcP Vaccine in Healthy Children Aged Between 2 Months and 6 Years

Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using of the vaccine targeted the three components, it greatly reduced incidence of the three kinds of diseases. The Purpose of this study is to preliminary evaluate the safety of DTcP compared to adsorbed diphtheria and tetanus combined vaccine （DT），Diphtheria-tetanus-acellular pertussis vaccine（DTaP） or PENTAXIM（DTaP-IPV-Hib） in participants.

Study Overview

• Status: Completed
• Conditions: Pertussis; Tetanus; Diphtheria
• Intervention / Treatment: Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed; Biological: Diphtheria and Tetanus Combined Vaccine, Adsorbed; Biological: Diphtheria-tetanus-acellular pertussis vaccine; Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine

Detailed Description

Study participants will receive a single booster dose of DTcP or a single booster dose of local DT in 4 to 6 years old ,a singel booster dose of DTcP or a single booster dose of DTaP in 18 to 24 months, three basic doses of DTcP or three doses of DTaP/ DTaP-IPV-Hib in 2 to 6 months.Safety profile will be assessed in all subjects up to Day 30 post vaccination.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Henan
    • Xuchang, Henan, China, 461500
      • Changge Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 6 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy subjects aged 2months、3months、18-24months and 4-6 years old;
• Willing to provide proof of identity;
• Able to understand and sign the informed consent by guardians or trustees;
• Able and willing comply with the requirements of the protocol by guardians or trustees;
• Subjects of 2 months age have not been vaccinated with diphtheria, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine;
• Subjects of 3 months have not been inoculated with vaccines containing diphtheria, Hib, 13-valent pneumococcal polysaccharide conjugate vaccine and Meningococcal Group AC Bivalent Meningococcal Conjugate Vaccine;volunteers of 3 months (C3 group) have not been inoculated with vaccines containing IPV;
• Subjects aged 18-24 months who had completed the immunization program of 3 doses of DTaP and had without the fourth DTaP vaccine ;
• Subjects aged 4-6 years who have completed the immunization program of 4 doses of DTaP or similar vaccines containing DTP component, but who have not received DT vaccine;

Exclusion Criteria:

• Premature birth in infant under 1 year of age (delivery before the 37th week of pregnancy)or low birth weight (birth weight< 2300g for girls,<2500g for boys);
• History of abnormal labor process or asphyxia rescue ;
• Subjects who has a medical history of diphtheria, pertussis or tetanus;
• In the past 30 days, individuals who have had contact with individuals with confirmed pertussis, diphtheria and tetanus diseases in their families;
• Allergic person;
• Any prior administration of blood products in last 3 month;
• Any prior administration of other research medicines in last 1 month;
• Plans to participate in or is participating in any other drug clinical study;
• Any prior administration of attenuated live vaccine in last 14 days;
• Any prior administration of subunit or inactivated vaccines in last 7 days;
• Had fever before vaccination, Subjects with temperature >37.0°C on axillary setting;
• According to the investigator's judgment, the subjects have any other factors that make them unfit to participate in the clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vaccine 1A; Subjects received one dose of DTaP aged 4 to 6 years.	Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed; 0.5 mL, Intramuscular Other Name: DTcP
ACTIVE_COMPARATOR: Vaccine 1B; Subjects received one dose of DT aged 4 to 6 years.	Biological: Diphtheria and Tetanus Combined Vaccine, Adsorbed; 2mL, Intramuscular Other Name: DT
EXPERIMENTAL: Vaccine 2A; Subjects received one dose of DTcP aged 18 to 24 months.	Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed; 0.5 mL, Intramuscular Other Name: DTcP
ACTIVE_COMPARATOR: Vaccine 2B; Subjects received one dose of DTaP aged 18 to 24 months.	Biological: Diphtheria-tetanus-acellular pertussis vaccine; 0.5 mL, Intramuscular Other Name: DTaP
EXPERIMENTAL: Vaccine 3A; Subjects received three doses of DTcP at 3,4,5 months of age.	Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed; 0.5 mL, Intramuscular Other Name: DTcP
ACTIVE_COMPARATOR: Vaccine 3B; Subjects received three doses of DTaP at 3,4,5 months of age.	Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed; 0.5 mL, Intramuscular Other Name: DTcP; Biological: Diphtheria-tetanus-acellular pertussis vaccine; 0.5 mL, Intramuscular Other Name: DTaP
ACTIVE_COMPARATOR: Vaccine 3C; Subjects received three doses of DTaP-IPV-Hib at 3,4,5 months of age.	Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine; 0.5 mL, Intramuscular Other Name: PENTAXIM
EXPERIMENTAL: Vaccine 4A; Subjects received three doses of DTcP at 2,3,4 months of age.	Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed; 0.5 mL, Intramuscular Other Name: DTcP
ACTIVE_COMPARATOR: Vaccine 4B; Subjects received three doses of DTaP-IPV-Hib at 2,3,4 months of age.	Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine; 0.5 mL, Intramuscular Other Name: PENTAXIM
EXPERIMENTAL: Vaccine 4C; Subjects received three doses of DTcP at 2,4,6 months of age.	Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed; 0.5 mL, Intramuscular Other Name: DTcP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety items of adverse reactions	Occurrence of adverse reactions	within 30 minutes post-vaccination
Safety items of adverse reactions	Occurrence of adverse reactions	within 7 days post-vaccination
Safety items of SAE: Occurrence of SAE	Occurrence of SAE	within 360 days post-vaccination
Safety itmes of laboratory measures: Occurrence of abnormal changes of laboratory measures	Occurrence of abnormal changes of laboratory measures	the fourth day post-vaccination
Safety items of adverse reactions	Occurrence of adverse reactions	within 8-30 days post-vaccination
Safety items of adverse reactions	Occurrence of adverse reactions	within 30 days post-vaccination

Collaborators and Investigators

• Sponsor: CanSino Biologics Inc.
• Collaborators: Henan Center for Disease Control and Prevention
• Investigators: Principal Investigator: Wang Yanxia, Henan Province Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 28, 2020
• Primary Completion (ACTUAL): October 27, 2021
• Study Completion (ACTUAL): November 25, 2021

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 20, 2019
• First Posted (ACTUAL): September 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Infection; Vaccine; Pertussis; Diphtheria; Tetanus; Whooping Cough; DTcP
• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neurologic Manifestations; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Neuromuscular Manifestations; Actinomycetales Infections; Clostridium Infections; Hypocalcemia; Calcium Metabolism Disorders; Corynebacterium Infections; Whooping Cough; Tetanus; Diphtheria; Tetany; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: CS-CTP-DTcP-Ⅰ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In order to maintain the rights of the subject, do not open the IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No